Earnings summaries and quarterly performance for RAPT Therapeutics.
Executive leadership at RAPT Therapeutics.
Board of directors at RAPT Therapeutics.
Research analysts covering RAPT Therapeutics.
Recent press releases and 8-K filings for RAPT.
RAPT Therapeutics Updates on Ozureprubart (RPT-904) Clinical Development
RAPT
New Projects/Investments
Guidance Update
- Ozureprubart (RPT-904), a next-generation anti-IgE drug, is being developed by RAPT Therapeutics for food allergy, chronic spontaneous urticaria (CSU), and asthma, aiming for less frequent dosing and broader patient access compared to Xolair.
- A Chinese Phase 2 CSU study demonstrated that Ozureprubart at Q8 and Q12 week dosing provided comparable or numerically superior results to omalizumab (Xolair) in UAS7 scores, with durability extending up to 16 weeks and a favorable safety profile.
- RAPT plans to advance Ozureprubart into two Phase 3 pivotal studies for CSU, each enrolling 300-350 patients, with the primary endpoint being UAS7 at week 12.
- The Prestige study, a 100-patient placebo-controlled Phase 2 trial for food allergy, initiated in October, is evaluating Q8 and Q12 week dosing in adolescents and adults, with a primary endpoint at 24 weeks.
- Data from a PKPD study in asthma, conducted by partner Shanghai Jeyou Pharmaceutical, focusing on free IgE reduction, is expected by year-end.
Nov 13, 2025, 7:30 PM
RAPT Therapeutics Provides Update on Ozureprubart Clinical Development and Financials
RAPT
New Projects/Investments
Guidance Update
- RAPT Therapeutics' lead asset, ozureprubart (RPT-904), an anti-IgE, omalizumab biobetter, is being developed for food allergy and chronic spontaneous urticaria (CSU), targeting multi-billion dollar market opportunities.
- The company reported numerically superior efficacy for ozureprubart compared to omalizumab in a Phase 2 CSU trial across all endpoints and time points, even after a single dose out to week 16, with plans to initiate Phase 3 studies next year.
- A Phase 2b study for food allergy commenced at the end of October, with a readout anticipated in early 2027.
- RAPT's pro forma cash balance was $392 million at the end of Q3, providing a projected cash runway into mid-2028.
Nov 12, 2025, 7:40 PM
Remedy Plan Therapeutics Announces RPT1G Phase 1 Safety Data and IND Clearance
RAPT
Product Launch
New Projects/Investments
- RPT1G, a NAMPT inhibitor developed by Remedy Plan Therapeutics, demonstrated safety and good tolerability in a Phase 1 study in healthy volunteers at single and multiple ascending dose levels.
- The FDA has cleared Remedy Plan's Investigational New Drug (IND) application for RPT1G, allowing it to proceed with a Phase 1 study in patients with relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes/neoplasms (HR-MDS).
- Remedy Plan Therapeutics also received orphan drug designation for RPT1G in AML from the FDA.
Nov 12, 2025, 1:00 PM
RAPT Therapeutics Provides Update on Zutalizumab Clinical Development and Financial Outlook
RAPT
New Projects/Investments
Guidance Update
- RAPT Therapeutics' lead asset, zutalizumab (RPT-904), is a long-acting anti-IgE antibody designed for less frequent dosing and to treat patients currently inaccessible to omalizumab.
- The company initiated its Phase 2b Prestige study for food allergy, with topline data expected in the first half of 2027. This study includes both omalizumab-eligible and ineligible patients.
- For Chronic Spontaneous Urticaria (CSU), Phase 2 data showed 16-week durability with a single dose of zutalizumab, numerically superior to omalizumab. RAPT plans to interact with the FDA next year and start Phase 3 trials before the end of next year, with a go-forward dose of 300 mg Q12 week.
- RAPT reported a pro forma cash balance of approximately $392 million after a recent raise, providing a projected runway through mid-2028.
- The company anticipates zutalizumab to be clinically differentiated from Xolair and its biosimilars due to less frequent dosing and the ability to treat omalizumab-ineligible patients, with payers potentially reimbursing at a 15-20% premium.
Nov 11, 2025, 8:30 PM
RAPT Therapeutics Reports Q3 2025 Results, Announces Positive Clinical Data, and Strengthens Balance Sheet
RAPT
Earnings
New Projects/Investments
- RAPT Therapeutics reported a net loss of $17.6 million for the third quarter of 2025 and a net loss of $52.4 million for the nine months ended September 30, 2025.
- As of September 30, 2025, the company held $157.3 million in cash, cash equivalents, and marketable securities.
- In October 2025, RAPT completed a public offering of 8,333,334 shares at $30.00 per share, generating gross proceeds of $250 million and projecting its cash balance to fund operations until mid-2028.
- The company initiated the prestIgE Phase 2b trial of ozureprubart in food allergy and announced positive topline data from a Phase 2 trial of ozureprubart in chronic spontaneous urticaria (CSU), indicating comparable efficacy and safety to omalizumab.
Nov 6, 2025, 1:02 PM
Rapport Therapeutics Reports Third Quarter 2025 Financials and Provides Business Update
RAPT
Earnings
Guidance Update
New Projects/Investments
- Rapport Therapeutics reported a net loss of $26.9 million for the third quarter of 2025, with research and development expenses of $22.3 million and general and administrative expenses of $7.7 million.
- The company's cash, cash equivalents, and short-term investments totaled $513.0 million as of September 30, 2025, significantly increased by $269.4 million in net proceeds from a recent public offering. This capital is expected to fund operations into the second half of 2029.
- Positive topline results from the Phase 2a clinical trial of RAP-219 in focal onset seizures showed a 77.8% median reduction in clinical seizures. The company plans to initiate two Phase 3 pivotal trials for RAP-219 in FOS in the third quarter of 2026.
- The Phase 2 trial of RAP-219 for bipolar mania is currently enrolling patients, with topline results expected in the first half of 2027.
Nov 6, 2025, 12:00 PM
RAPT Therapeutics Announces Positive Phase 2 Topline Results for RPT904 in Chronic Spontaneous Urticaria
RAPT
Study Result
New Projects/Investments
- RAPT Therapeutics announced positive Phase 2 topline results for RPT904 (JYB1904) in Chronic Spontaneous Urticaria (CSU) on October 20, 2025.
- RPT904 at both Q8W and Q12W dosing showed comparable efficacy and safety to omalizumab at Q4W dosing, with numerically superior efficacy on UAS7 and UAS7=0 (complete response) across all timepoints.
- RPT904 was well tolerated with no drug-related serious adverse events (SAEs) or discontinuations, and no adverse events of special interest (e.g., anaphylaxis).
- A single 300 mg dose of RPT904 demonstrated numerically superior efficacy to four 300 mg doses of omalizumab at week 16.
- These results support moving RPT904 to pivotal Phase 3 studies in CSU.
Oct 20, 2025, 12:30 PM
RAPT Announces Positive Phase II Results for RPT-904 in Chronic Spontaneous Urticaria
RAPT
New Projects/Investments
- RAPT announced positive top-line results from a Phase II clinical trial of RPT-904 in patients with chronic spontaneous urticaria (CSU), conducted by its partner JU in China.
- Both RPT-904 dosing arms (every 8 or 12 weeks) demonstrated numerically superior efficacy compared to omalizumab (every 4 weeks) on the primary endpoint (UAS7) and complete response (UAS7=0) at all measured time points (weeks 8, 12, and 16).
- The RPT-904 Q12 week arm, with only a single dose, showed sustained numerically superior efficacy up to 16 weeks, indicating high durability.
- RPT-904 was well tolerated with no drug-related serious adverse events or discontinuations.
- These results support advancing RPT-904 into pivotal Phase III studies for CSU, and RAPT plans to initiate a Phase IIb trial for RPT-904 in food allergy by year-end.
Oct 20, 2025, 12:30 PM
RAPT Therapeutics to Report Topline Data for RPT904 Phase 2 Clinical Trial
RAPT
New Projects/Investments
- RAPT Therapeutics plans to report topline data from the Phase 2 clinical trial of RPT904 (JYB1904) in patients with Chronic Spontaneous Urticaria (CSU).
- The data will be released in a premarket press release and webcast on Monday, October 20, 2025.
- RAPT will host a webcast conference call at 8:30 a.m. ET on October 20, 2025, to discuss the results.
Oct 19, 2025, 12:00 PM
RAPT Therapeutics Announces FDA Clearance for RPT904 Phase 2b Trial
RAPT
New Projects/Investments
- RAPT Therapeutics announced on September 29, 2025, that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of RPT904 for the treatment of patients with food allergy.
- The planned Phase 2b trial, named "prestIgE", is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of RPT904 dosed every 8 weeks (Q8W) and every 12 weeks (Q12W).
- The company is on track to initiate this Phase 2b clinical trial by the end of the year.
- RPT904 is a novel, half-life extended anti-IgE monoclonal antibody designed to inhibit human immunoglobulin E (IgE), a key driver of allergic diseases, and has demonstrated extended pharmacokinetics and pharmacodynamic properties compared to omalizumab in early clinical studies.
Sep 29, 2025, 9:01 AM
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more